FDA UDI In Commercial Distribution 🇺🇸 United States

IDS-iSYS Diluent B

DI: 05060169691100 · Model: IS-10DB · IMMUNODIAGNOSTIC SYSTEMS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
IDS-iSYS Diluent B
Primary DI
05060169691100
Version / Model
IS-10DB
Company Name
IMMUNODIAGNOSTIC SYSTEMS LIMITED
Labeler DUNS
494268600
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-04-01
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
5d751b53-02cf-4ff9-981c-9cfb64ff660f

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

GMDN Terms

Code Name
57769 Immunohistochemistry antibody diluent IVD

Identifiers

Type ID
Primary 05060169691100

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 8 Degrees Celsius
Type
Handling Environment Temperature
Temperature Range
2 – 8 Degrees Celsius
Type
Special Storage Condition, Specify
Special Conditions
Store upon receipt at 2 to 8 degrees celsius